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Job Details

Sr. Scientist Biologics Fermentation/Cell Culture

Location
San Francisco, CA, United States

Posted on
Jan 06, 2021

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Position Overview

Nektar has an exciting opportunity for a Sr. Scientist, Biologics Fermentation/Cell Culture to join their External Manufacturing Team.

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Nektar has an exciting opportunity for a Sr. Scientist, Biologics Fermentation/Cell Culture to join their External Manufacturing Team.

Description:

Participates and occasionally leads in developing recombinant protein production processes. Main focus is the development, optimization and characterization of microbial fermentation, mammalian cell culture and primary recovery processes. Designs and executes fermentation and mammalian cell culture processes to express recombinant proteins in addition to performing primary recovery activities. Bioreactor set up and operational experience is critical as well as well as a deep understanding of how to analyze product quality attributes using basic analytical techniques, i.e. SDS-PAGE, HPLC, etc. The successful candidate will participate in technology transfer of processes to CROs/CMOs and oversee process development, scale-up and/or GMP production activities at CMOs. This position requires review and/or authorship of CMC sections of regulatory filing documents. This position will also contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Essential Duties and Responsibilities

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments. The candidate will develop, optimize and characterize microbial fermentation, mammalian cell culture and primary recovery processes. Designs and executes fermentation and mammalian cell culture processes to express recombinant proteins. Ability to set up and operate bioreactors (stainless steel and single use) is critical. Bioreactor scale can span between 10L to 250L.The candidate will also have experience in primary recovery activities. Analyzes quality of expressed proteins using basic analytical techniques, i.e. SDS-PAGE, HPLC, etc. Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervision. Defines complex problems, and develops experiments with sound judgment. Interfaces with various departments and partners and has demonstrated strong team leadership skills. Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements and has knowledge of GMP practices. The candidate will assist with implementing organizational systems, identifying and purchasing capital equipment, and projecting resource requirements. May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.

Minimum Qualification Requirements

Requires a PhD in a scientific discipline and 5 years related experience; MS in a scientific discipline and a minimum of 10 years related experience; BS in a scientific discipline and minimum 15 years related experience. A minimum of 5 years work experience in a biotechnology/pharmaceutical industry, preferably in a GMP manufacturing environment, is required.

Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in the field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to biologics manufacturing practices are highly desired. Experience with regulatory filings is a plus. Previous management experience is a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. **MEMBERS ONLY**SIGN UP NOW***. will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

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